Senior Quality Assurance Representative

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Merck Group's Senior Quality Assurance Representative in Indianapolis is a day shift QA role overseeing manufacturing activities with a focus on cGMP compliance, line clearances, aseptic technique, and GMP violation reporting. Ideal candidates have a life science degree with 2+ years GMP experience, or a high school diploma with 5+ years, plus aseptic gowning qualification and SME status. Strong documentation discipline, Excel and SAP familiarity, and knowledge of EU Annex 1 areas A through D are preferred. This onsite role offers a competitive pay range and benefits; sponsorship is not provided. Tips: tailor your resume to GMP QA, highlight aseptic expertise, demonstrate collaboration and problem solving, and apply via the company's careers page.

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

This role provides day shift support as quality assurance on-the-floor oversight for manufacturing activities at the facility.

Responsibilities include but are not limited to:

• Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed.
• Performs and documents line clearances and room release for manufacturing use.
• Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented.
• Monitors the formulation and filling processes to ensure cGMP compliance.
• Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators.  Requires qualification in aseptic gowning and certification as an aseptic processing SME.
• Observers, reports, and documents operator cleaning and disinfection practices.
• Documents, reports, and trends observations stemming from Quality Oversight.
• Documents and reports to management GMP violations, unsafe conditions, or other unusual results or practices.
• Monday - Friday 8am - 4:30pm.

Physical Attributes:

• Lift and/or move up to 25 pounds.
• Wear appropriate Personal Protective Equipment. 

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Biology, Chemistry, or other Life Science Discipline and 2+ years of GMP pharmaceutical industry experience.

OR

• High School Diploma or GED and 5+ years of GMP pharmaceutical industry experience.

Preferred Qualifications:

• Experience with computer software applications including Microsoft Excel, Word, and Access.
• Experience with Quality Management computer systems and SAP.
• Experience with EU Annex 1 classified areas A, B, C, and D including acceptable aseptic behaviors, practices, and gowning.

Pay Range for this position: $69,200 - $110,900 / year​

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. 

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